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Overweight and Obese AdultsDREAMNCT07255287

Behavioral Weight Loss and Sleep Health Intervention

A study testing BWL+Sleep in people with Overweight and Obese Adults, run by University of Colorado, Denver at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a 6-month single-arm pilot and feasibility study designed to examine if a behavioral weight loss (BWL) intervention with an added sleep health program (BWL+SLEEP) can achieve clinically meaningful weight loss and improvements in a composite sleep health score. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Overweight and Obese Adults
What is being tested?
BWL+Sleep
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteUnited States
Study dates
10 Dec 2025to 31 Jul 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Body Mass Index 25-40 kg/m2
  • Suboptimal sleep defined as: 1) short sleep duration (actigraphy total sleep time <6.5 hrs/night), 2) sleep irregularity (actigraphy standard deviation, SD of wake time, bed time or sleep duration >60 min), 3) poor sleep satisfaction/quality (Pittsburgh Sleep Quality Index, PSQI single item sleep quality question response of "fairly bad" or "very bad"), 4) suboptimal sleep timing (actigraphy sleep midpoint before 2 AM or after 4 AM), 5) daytime sleepiness (Epworth Sleepiness Scale, ESS >10) and/or 6) suboptimal sleep efficiency (actigraphy sleep efficiency <85%).
  • Physically Inactive: defined as <150 minutes per week of exercise at moderate intensity or greater and <60 min per day of total habitual physical activity (i.e., work related, transportation related) at moderate intensity or greater, over the past 3 months.
  • No self-report of acute or chronic disease (cardiovascular disease (CVD), diabetes, pulmonary, gastrointestinal disorders, and orthopedic problems in particular).
  • No plans to relocate within the next 12 months.
  • No plans for extended travel (>2 weeks) within the next 12 months.
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  • Live or work within 30 minutes of the AHWC (exceptions may be made at the discretion of the Study PI).
  • Capable and willing to give informed consent, understand exclusion criteria, and accept the randomized group assignment.
  • Own or willing to purchase a smartphone, willing to download and use the Oura Ring and/or Headspace App if randomized to these components. (Data from the Pew Research Center 2024 Mobile Fact Sheet suggests >95% of adults in our target age range own a smartphone)
  • Have a primary care physician (or are willing to establish care prior to study enrollment) to address any medical issues which may arise during screening procedures or study interventions.
  • No contraindications to exercise or limitations on ability to be physically active.
  • Agree to refrain from use of anti-obesity medications (AOMs) agents during the 6-month pilot study.
  • For Females:
  • Not currently pregnant or lactating,
  • Not pregnant within the past 6 months,
  • Not planning to become pregnant in the next 12 months. Sexually active women of childbearing potential may be enrolled if they have had a tubal ligation or use a reliable means of contraception.

Who cannot join

  • Diastolic blood pressure >100 mmHG, systolic blood pressure >160 mmHG, or resting heart rate >100 bpm as measured in duplicate on the screening visit after 5 minutes of rest in a seated position.
  • Diabetes (fasting glucose greater than or equal to 126 mg/dL or Hemoglobin A1C greater than or equal to 6.5%) as measured during the screening visit.
  • Undiagnosed hypo- or hyper-thyroid (TSH outside of the normal range as measured during the screening visit) or history of uncontrolled thyroid disorder. History of thyroid disease or current thyroid disease treated with a stable medication regimen for at least 6 months is acceptable.
  • Hematocrit, white blood cell count or platelets significantly outside the normal reference range as measured on the screening visit.
  • Triglycerides >400 mg/dL as measured on the screening visit.
  • LDL cholesterol >200 mg/dL as measured on the screening visit.
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  • Abnormal resting electrocardiogram (ECG) as measured on the screening visit: serious arrhythmias, including multifocal PVC's, frequent PVC's (defined as 10 or more per min), ventricular tachycardia (defined as runs of 3 or more successive PVC's), or sustained atrial tachyarrhythmia; 2nd or 3rd degree A-V block, QTc interval > 480 msec or other significant conduction defects.
  • Presence or history of any metabolic or chronic health problems which would affect appetite, food intake, energy metabolism, or ability to participate in physical activity: cardiovascular disease (CVD), peripheral vascular disease, cerebrovascular disease, significant cardiac arrhythmias or cardiac valve disease, diabetes, uncontrolled hyper- or hypothyroidism, uncontrolled hypertension, cancer (within the last 5 years, except skin cancer or other cancers considered cured with excellent prognosis), HIV infection (unless treated with undetectable viral load), significant gastrointestinal disorders (described below), significant pulmonary disorders (described below), significant renal, musculoskeletal, neurologic, hematologic, or psychiatric disease.
  • Significant gastrointestinal disorders including chronic malabsorptive conditions, active peptic ulcer disease, Crohn's disease, Ulcerative Colitis, chronic diarrhea, or active gallbladder disease.
  • Significant pulmonary disorders including chronic obstructive pulmonary disease (COPD), interstitial lung disease, cystic fibrosis, or uncontrolled asthma.
  • Symptoms suggestive of CVD: chest pain, shortness of breath at rest or with mild exertion, syncope.
  • Primary sleep disorders including but not limited to chronic insomnia >= 3 months, untreated moderate-to-severe sleep apnea (apnea hypopnea index, AHI greater than or equal to 15), narcolepsy periodic limb movements in sleep, parasomnias including sleepwalking or night terrors, Insomnia Severity Index (ISI) Score greater than or equal to 15.
  • *Note: If we find that too many screened participants are ineligible based on AHI greater than or equal to 15, we will consider increasing AHI threshold to greater than or equal to 30 in order to improve generalizability results.
  • *Note: If we find that too many screened participants are ineligible based on ISI greater than or equal to 15, we will consider increasing ISI threshold to greater than or equal to 22 in order to improve generalizability results.
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  • Night-time shiftwork, rotating work, or other circadian disruptions and disorders (e.g., diagnosed delayed sleep-wake phase disorder).
  • Regular use (greater than or equal to 2 days/wk) of prescription sleep medications (e.g., benzodiazepines, doxepin, zolpidem, trazodone, etc.).
  • Regular use of other prescription or over-the-counter medications known to affect appetite, weight, sleep, or energy metabolism (e.g., lithium, stimulants, anti-psychotics, tricyclic antidepressants).
  • Regular use of systemic glucocorticoids (except physiological doses for replacement therapy in adrenal insufficiency).
  • Regular use of anti-obesity medications (AOMs) within the last 6 months, plans to begin AOMs in the next year.
  • Previous obesity treatment with surgery or weight loss device, except: (1) liposuction and/or abdominoplasty if performed > 1 year before screening, (2) lap banding if the band has been removed > 1 year before screening, (3) intragastric balloon if the balloon has been removed > 1 year before screening (4) duodenal-jejunal bypass sleeve, if the sleeve has been removed > 1 year before screening or 5) AspireAssist or other endoscopically placed weight loss device if the device has been removed > 1 year before screening.
  • Current alcohol or substance abuse.
  • Nicotine use (current or quit in the past 6 months).
  • History of clinically diagnosed eating disorders including anorexia nervosa, bulimia, binge eating disorder. Score >20 on the Eating Attitudes Test (EATS-26) or pattern of response on the Questionnaire of Eating and Weight Patterns (QEWP-5) suggestive of possible binge eating disorder or bulimia will require further assessment by the Study MD to determine if it is appropriate for the subject to participate in the study.
  • Current severe depression or history of severe depression within the previous year, based on DSM-IV-TR criteria for Major Depressive Episode. Score > 16 on the Center for Epidemiologic Studies Depression Scale (CES-D) will require further assessment by the Study MD to determine if it is appropriate for the subject to participate in the study.
  • History of other significant psychiatric illness (e.g., psychosis, schizophrenia, mania, bipolar disorder) which significantly impacts sleep or which in the opinion of the Study MD would interfere with ability to adhere to the interventions.
  • Currently participating in or planning to participate in any formal weight loss programs, physical activity programs, sleep health programs, or clinical trials.
  • Weight change of +/- 5 kg in past 3 months.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Colorado Anschutz Medical Campus, Aurora, Colorado 80045

    Aurora, Colorado, 80045

Other trials in United States

About this study

Official title: Behavioral Weight Loss Plus Sleep Health Program (BWL+SLEEP) Feasibility Pilot Study

This is a 6-month single-arm pilot and feasibility study designed to examine if a behavioral weight loss (BWL) intervention with an added sleep health program (BWL+SLEEP) can achieve clinically meaningful weight loss and improvements in a composite sleep health score. The investigators will also evaluate the feasibility of recruitment and retention of study participants and will obtain feedback from participants to improve the program's incorporation of strategies to improve sleep health.

Being tested
BWL+Sleep
Keywords
overweight, obese, sleep, weight loss
Medical subject headings
Overweight, Obesity, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BWL+SleepBehavioural

    Participants will receive a 6-month group-based behavioral weight loss intervention that incorporates strategies to improve sleep health.

Study groups in NCT07255287
Study groupRoleWhat they receive
Behavioral Weight Loss Program Plus Sleep Health InterventionExperimentalParticipants will receive a 6-month group-based behavioral weight loss intervention that incorporates strategies to improve sleep health.
Receives: Behavioral: BWL+Sleep

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of enrollment

    Feasibility of enrollment will be assessed by whether the study team can enroll the target sample size of n=20 individuals in the study over a 3-4 month period.

    Measured: Baseline

  2. Feasibility of Outcome Measure Completion

    Outcome measure completion will be calculated by dividing the number of participants who complete outcome measures at each timepoint by the total number enrolled.

    Measured: 6 months

  3. Intervention Acceptability

    Intervention acceptability will be assessed using validated questionnaires that assess acceptability of intervention components on a 1-5 scale.

    Measured: 6 months

  4. Retention

    Retention will be assessed by dividing the number of participants completing the 6-month study by the total number that were enrolled.

    Measured: 6 months

Secondary outcomes (2)

  1. Weight change (kg)

    Body weight will be measured using a digital scale, accurate to =/-0.1 kg, in the morning in a fasted state, at baseline, 3, and 6 months. The primary outcome will be change in weight from baseline to 6 months.

    Measured: Baseline (0) - 6 Months

  2. Composite sleep health score

    The Composite Multidimensional Sleep Health Score will be assessed at baseline, 3, and 6 months. Scores range from 0-6, with a higher score indicating better sleep.

    Measured: Baseline (0) - 6 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Dec 2025
  2. Study start10 Dec 2025
  3. Primary completion31 Jul 2028 (estimated)
  4. Study completion31 Jul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07255287
Sponsor's protocol ID
23-1317
Other IDs
1K24HL169755
Acronym
DREAM
Status last verified
Aug 2026
First submitted
31 Oct 2025
Last updated
3 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Given that this research is designed to develop a novel behavioral intervention (BWL+SLEEP) and collect preliminary data to support the submission of a future grant application (by the investigative team) designed to test the weight loss efficacy of the novel intervention, only data supporting publication(s) will be made available. Subset(s) of the full, clean dataset that demonstrate the principles outlined in a resulting publication(s) will be shared in a controlled access repository. All data that can be shared will be de-identified before reaching the repository.

Questions about this trial

What is this clinical trial studying?

A study testing BWL+Sleep in people with Overweight and Obese Adults, run by University of Colorado, Denver at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of enrollment (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07255287.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.

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